Clobazam
- Product NDC
- 59651-401
- 11-digit product format
- 596510401
- Labeler code
- 59651
- Product ID
- 59651-401_df4d6b4b-9864-4c24-92e1-4a72c2863b5f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clobazam
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA214404
- Marketing category
- ANDA
- Marketing start
- 2022-03-24
- Substance
- CLOBAZAM
- Active strength
- 2.5 mg/mL
- Pharmacologic classes
- Benzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clobazam
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOBAZAM | 2.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2MRO291B4U |
| Rxcui | 1366192 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-401-12 | Clobazam | 1 in 1 CARTON | SUSPENSION | 1 | | 4 |
| 59651-401-12 | Clobazam | 120 mL in 1 BOTTLE | SUSPENSION | 120 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-401 | CLOBAZAM SUSPENSION [AUROBINDO PHARMA LIMITED] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240417_1b5749a1-1c6d-4243-a833-4bfd84f9d5a9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59651-401-12 | 59651040112 | 1 BOTTLE in 1 CARTON (59651-401-12) / 120 mL in 1 BOTTLE | 1 bottle | 2022-03-24 | 0000-00-00 | No | No | Current |